Somatic Stem Cells in Leiomyomas?

August 30, 2016 updated by: Carlos Simon, Igenomix

Identification and Characterization of Putative Leiomyoma Stem Cells.

The purpose of this study is to identify and characterize the Somatic Stem Cell (SSC) responsible for the formation and growth of leiomyomas using the Side Population method.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The organ of interest in our study is the myometrium, a muscle layer of the uterus located between the perimetry and the endometrium.

The investigators try to identify, locate and characterize the myometrial stem cell population in the uterine fibroids by isolation of "Side Population" by flow cytometry. Once the investigators achieve the purposes to set out, the investigators would try to maintain "in vitro" stem cell population isolated from myometrial fibroids, for further endocrine characterization. Finally, the investigators would try to induce the formation of fibroids in murine models as a first step to demonstrate that the origin of these formations is due to the abnormal proliferation of myometrial adult stem cells. The results of this study will allow the identification of the cell population in the fibroids. The investigators also can being able to compare with the myometrium in order to establish a relationship that helps us to understand more about the pathophysiology of this disease, using these stem cells as targets therapy in the treatment of this myometrium condition.

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46015
        • IVI Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Female patients from 20 years and older undergoing laparoscopic myomectomy for symptomatic uterine fibroids.

Description

Inclusion Criteria:

  • Clinical diagnosis for subserosal, intramural and submucosal fibroids.
  • Aged between 20 and 40 years
  • Signing of informed consent for collection and storage of biological samples.

Exclusion criteria:

  • Contraindications for surgery.
  • Failure to sign informed consent for collection and storage of biological samples.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with symptomatic uterine fibroids.
Samples of human leiomyomas are obtained from patients undergoing laparoscopic myomectomy for symptomatic uterine fibroids. These leiomyomas are isolated and cultured for stem cells.
Genetic: Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.
  • Obtention of one part of removed human leiomyoma after surgery and maintained in 4ºC until procedures.
  • Sample digestion through controlled enzymes.
  • Isolated the "Side Population" from leiomyoma cell suspension by Flow cytometry .
  • Culture of these cells.
  • Morphological and genetic characterization.
  • Assessment of pluripotent potential from isolated cells.
  • Analysis of the degree of functionality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Formation and growth of human leiomyomas
Time Frame: 36 months
Assessment of pluripotent potential from isolated cells responsible for the formation and growth of human leiomyomas.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Igenomix

Investigators

  • Principal Investigator: Carlos Simon, MDPhD, Igenomix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 3, 2012

First Submitted That Met QC Criteria

May 4, 2012

First Posted (Estimate)

May 7, 2012

Study Record Updates

Last Update Posted (Estimate)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1006-C-072-CS-F

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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